BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW PAIN BUSTER

    MDR report key: 1071560 · Received July 9, 2008

    Report

    Report Number
    MW5007562
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    December 19, 2003
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003-LEFT SHOULDER ARTHROSCOPY FOR INSTABILITY, LABRAL DEBRIDEMENT, AND ANTERIOR SHOULDER CAPSULORRHAPHY. PAIN BUSTER CATHETER INSERTED IN THE JOINT. IN 2006, MASSIVE CHONDROLYSIS IN LEFT SHOULDER AT THE AGE OF 28 YRS OLD. LEAD TO: LEFT SHOULDER RESURFACING HEMIARTHROPLASTY IN 2007. IN 2003, PAIN BUSTER PAIN PUMP PLACED IN LEFT SHOULDER JOINT. DOSE OR AMOUNT: 300 ML. FREQUENCY: OVER 3 DAYS. ROUTE: 014. DATES OF USE: FOUR DAYS IN 2003. DIAGNOSIS OR REASON FOR USE #1: LEFT SHOULDER INSTABILITY. #2: LABRAL DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW PAIN BUSTER PAIN BUSTER MEB I-FLOW CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.5% MARCAINE 300 ML